1. Field of the Invention
This invention relates to an apparatus for controlling the temperature of an area of the body for therapy or for improved recovery following surgery.
2. Description of the Prior Art
It has been found that to improve patient healing and recovery by reducing pain, swelling, and blood loss, post-operative procedures increasingly employ means for reducing the temperature in the area of the body around the surgery.
For example, after a knee operation, an ice pack or other device for reducing the temperature is applied to the area around the surgery. The area of incision, after closure, may be initially covered with a light sterile gauze. At one time, after knee surgery, the leg and knee would simply be covered with additional sterile gauze, additional sterile padding and finally wrapped from the toe to the groin with an elastic, ace bandage until the first dressing change. The ace bandage caused a compression on the leg that tended to reduce swelling and decreased the likelihood of phlebitis. Early attempts to reduce the temperature following knee surgery included applying ice packs or the like to the surface of the ace bandage in the knee area. However, the padding and bandage insulated the surgical area and made the cooling ineffective for properly reducing pain, swelling and/or blood loss.
If there were to be a means for more efficiently directing cold to the area of surgery, it would preferably be capable of extended and controlled generation of a reduced temperature. Although such a device for controlling temperature need not lie immediately against the area of incision, proper post-operative procedures require that all of the components employed in the surgical area be properly sterilized.
It would seem possible that any prior art means for holding a heat source or a cold source, such as ice, might be employed to significantly improve the likelihood that the source could be maintained in a proper position on the patient. However, a number of such devices which are primarily used for therapeutic procedures have not been found to be appropriate for post-operative procedures. Some such therapeutic devices include electrical heating pads or bandages such as those disclosed in U.S. Pat. Nos. 4,042,803; 4,107,509; and 4,736,088. Some heating pad configurations employ pouch devices in which warm water or chemical substances, which combine to form heat, are installed for the therapeutic application of heat to the patient. Such devices have been disclosed in U.S. Pat. Nos. 3,815,610; 4,470,417; and 4,742,827.
Because the preferred post-operative procedure would include means for cooling the area of the surgery, various devices, which are primarily intended to cool an area of a body, would appear to be more significant. However, some cooling devices are for use on animals rather than people. They tend to employ ice which is subject to melting or a means for directing cool liquid to the area but do not appear to have any direct application in a post-operative environment. Such devices are disclosed in U.S. Pat. Nos. 1,860,847; 3,905,367; 3,822,705; 4,033,354; and 4,556,055. U.S. Pat. No. 1,860,847 discloses a ring-shaped flexable bag for hot or cold water for the treatment of cold, influenza or similar ailments.
A more extensive number of devices have been suggested for the therapeutic application of heat or cold to the human body. Such devices typically include some form of support device or wrapping device having pouches or pockets for the insertion of a hot pack or a cold pack. The cold pack may contain ice or some chemically reactive material for producing a lower temperature. Since these devices employ hot water and/or cold water or ice, the amount of time that such a device can be employed is clearly limited. The loss of heat or cold may be acceptable for therapeutic uses but is clearly undesirable for post-operative procedures. Such devices for use on various parts of the body are disclosed in U.S. Pat. Nos. 3,882,873; 4,081,150; 4,372,318; 4,586,506; 4,527,566; 4,614,189; 4,688,572; 4,753,240; and 4,753,241.
Because of the limited heating or cooling duration of the various devices discussed hereinabove, there was clearly a need for some system which is capable of applying a continuously adjustable and monitored source of heat or cold to a desired area of the body. U.S. Pat. Nos. 4,459,468 and 4,844,072 are directed to temperature controlled, fluid circulating systems which, perhaps, best represent the type of systems which are enjoying increased acceptance in the therapeutic as well as the surgical field. These particular fluid circulating systems are designed for use with a thermal blanket or pad and includes temperature controls so that both heating and cooling effects could be selectively produced through the preheating or precooling of the fluid. The fluid is pumped through the thermal blanket to provide proper heating or cooling as desired at the location of the thermal blanket. For this purpose, the thermal blanket includes supply and discharge hose means which can be conveniently coupled to and uncoupled from the overall system. For proper operation of the overall system, various sizes and shapes of thermal blankets are provided for heating or cooling different areas on the patient.
Similar fluid circulating systems are disclosed in U.S. Pat. Nos. 3,674,034; 3,995,621; 4,026,299; 4,202,325; 4,335,726; 4,338,944; and 4,523,594.
U.S. Pat. No. 3,674,034 is directed to a system for maintaining controlled deep body temperature by providing heat to efficient areas of a person's body. The system includes a series of pouches which are individually strapped to the neck, each arm pit, and each upper thigh at the groin area of a person. Each pouch consists of a cloth covered tubing array and is connected to a hypothermia machine for controlling the temperature of the body in areas where the blood arteries are close to the skin surface. Since each pouch includes a thin, low-porosity and highly thermal-conductive fabric covering the tubing array therein, efficient heat transfer is produced without burning the patient. Each of the covers is said to be removable for laundering and sterilization. However, there is no suggestion that the device could or even should be utilized in a surgically sterile area for treatment of a patient.
The device disclosed in U.S. Pat. No. 3,995,621 includes a liquid cooled brassiere and is directed to a method of diagnosing malignant tumors. The device is not appropriate for nor applicable in post-operative procedures.
U.S. Pat. No. 4,202,325 is directed to a compression device having an improved fastening sleeve. The device is for applying compressive pressure against the patient's limb from a source of pressurized fluid and, again, has no post-operative application for directing heat or cold to a surgical area.
U.S. Pat. Nos. 4,335,726 and 4,338,944 disclose a therapeutic device with temperature and pressure controls. The therapeutic device includes a sleeve for covering a portion of a patient's body and has a space to receive cool circulating liquid. The device also incorporates means for applying pressure to the area of the patient to be cooled. As a result, it is recommended that this therapeutic device be used, for example, by sports trainers for the application of cold and pressure to the extremities, hands, feet, or joints of an athlete after a sprain or strain sustained during playing. Similarly, it is said that physicians in hospitals, such as emergency rooms, may employ such a device to apply cold and pressure to a patient in order accelerate healing by reducing edema and hematoma. If either such procedure were to periodically require heat, the overall therapeutic device could be readjusted for the periodic application of heat. There is no suggestion of the device being capable of being employed post-operatively.
U.S. Pat. No. 4,026,299 discloses a portable heating and cooling apparatus which utilizes flexible pads to be wrapped around a limb or other body portion of a human or animal. The portable apparatus is said to be especially useful for treating sprains, strains or other muscular injuries to athletes or race horses as soon after the injury occurs as possible in order to rapidly reduce swelling, fever or the like to the injured area. The overall system primarily employs flexible pads with a complicated array of flexible tubing loops which could be covered by a removable, non-insulating sheet which is intended to be applied to and lie against the patient's limb. This inner sheet could become soiled or worn and thus could be removed, washed or otherwise cleaned for sanitary purposes, or replaced. However, there is nothing to suggest that the apparatus would be appropriate for modern post-operative procedures which are performed in a surgically sterile environment.
U.S. Pat. No. 4,523,594 discloses a stretchable textile heat-exchange jacket. This heat-exchange jacket can be wrapped about and conform to a limb, an arm or a body member and function therapeutically to heat or cool the member. The jacket is formed of a sheet of elastic fabric material having an array of flexible plastic pipes threaded therethrough. The respective ends of the flexible pipes were coupled to an inlet fluid distributor and an outlet fluid collector. The elastic sheet is provided at its opposing sides with complimentary fabric fastener components to releasably hold the jacket securely in place on the body member even when the member is being flexed. Although this stretchable textile heat-exchanger jacket is clearly intended for therapeutic use during limited movement of a limb or joint, the general background of the invention discusses a possible use of cold following knee, leg or other surgery on an extremity where there is usually swelling in the vicinity of the incision.
U.S. Pat. No. 4,523,594 indicates that when the wound is dressed in a surgical bandage, it becomes difficult to apply ice to the site to reduce swelling and promote healing. Moreover, since surgical bandages, casts and rubberized braces used during rehabilitation are relatively impermeable to perspiration and act as thermal barriers, there is often a build-up of moisture and heat during a surgical dressing. This could create a climate conducive to bacteria. Such bacterial activity could cause infection and retard the healing process. The textile-heat exchange jacket is considered to be thin enough to be fitted under an "existing" surgical cast, bandage or brace without discomfort, whereby the jacket, when cold, could serve to reduce swelling and arrest perspiration in the wound area and also act to relieve post-operative itching.
The stretchable textile heat-exchanger jacket includes a rectangular sheet of fabric woven or otherwise fabricated of elastic cotton fibers, spandex or other natural or synthetic stretchable fabric material capable of being sterilized by conventional hospital procedures. However, threaded into the fabric sheet is a parallel array of flexible pipes formed of synthetic plastic material. While the pipes are stitched into the fabric sheet, most of the tubes surfaces are exposed and engage the body member when the jacket is wrapped thereabout. Alternatively, the sheet could take the form of two superimposed plies of open-mesh, stretchable fabric, with the pipes sandwiched therebetween in a manner in which the pipes form ducts between the plies.
Despite the discussions in U.S. Pat. No. 4,523,594 regarding possible use in surgical ares, the device disclosed therein is not particularly adapted for nor appropriate for post-operative procedures. The particular heat-exchange system is clearly intended to function therapeutically to heat or cool the member and even includes a suggestion of connecting the loop system to a water faucet of a house sink which then supplies tap water to the jacket. With the confusing arrangement of tubes connected to the stretchable jacket material, the entire system has been found to be too complicated to be practically employed in an operating room and poorly configured for post-operative use.
Despite the plurality of devices discussed hereinabove, an extensive number of surgeons do not employ any means for the post-operative reduction of temperature in the surgical area. This continues to occur despite the fact, as discussed hereinabove, that temperature reduction can be more conveniently and reliably directed to a surgical area with various types of thermal blankets or pads employed in a system such as those disclosed in U.S. Pat. Nos. 4,459,468 and 4,844,072. The blankets are provided extended, double hoses and couplings for convenient, quick and reliable connection to the overall system. Some fluid circulating blankets or pads, such as those disclosed in U.S. Pat. Nos. 4,114,620 and 4,149,541 are primarily intended for therapeutic use but are representative of the increased interest in flexible blankets for use with such temperature controlled, fluid circulating systems. Because the temperature of the blankets can be controlled for an extended period of time with the fluid circulating system, the blankets have been used in post-operative procedures as well as the initially intended therapeutic procedures. With limited but increasing acceptance of the blankets in post-operative procedures, it is not uncommon for the thermal blankets to be pre-sterilized for use in an operating room. Such sterilized blankets are disclosed in U.S. Pat. Nos. 3,867,939 and 4,951,665.
Although the thermal blankets themselves are a reliable and effective source of cold, the post-operative procedures with the blankets presently being employed by surgeons are extremely complicated, time-consuming and unreliable. Typically, for example, after a knee operation, two sterilized blankets are removed from sterile packages by a nurse. The blankets are to be directed to opposite sides of the knee, adjacent the specific area of the incision. An attending nurse is also required to remove at least two pieces of 4 inch by 8 inch sterile gauze which are packed in a peel pack. One or more sterile gauze pieces are then laid on the interior surfaces of the two blankets. The nurse must then orient the double hoses which extend from each blanket towards the foot of the patient. The nurse is usually positioned toward the body side of the knee with the surgeon positioned toward the foot side of the knee. Both blankets with the gauze pieces thereon are dispose, gauze up, for eventual alignment on either side of the knee area. Next, two sterile A.B.D. pads, which are thicker and about 5 inches by 10 inches, are removed from a peel pack for application on the outer side of each of the blankets. With the gauze thereon and with the A.B.D. pads applied to the outside of each blanket, it is not uncommon for the blankets and pads to be misaligned or poorly positioned against the opposite sides of the knee area by the nurse and/or the surgeon.
With the surgeon holding the sterile gauze, blanket, and A.B.D. pad in each hand against opposite sides of the knee, the nurse begins to wrap the knee area from the thigh to below the knee with a sterile gauze roll. It is not uncommon for the surgeon's hands to be partially enwrapped or for the blankets or pads to be further misaligned as the wrapping of the gauze roll proceeds through the knee area. The double hoses extending from the bottom of the blankets must be positioned to extend outwardly of the wrapping as it continues toward the foot. As a result, the hoses of the two blankets may be at different lengths or awkwardly positioned on one side or the other of the leg to complicate eventual connection to the overall fluid circulating system. For patients having shorter legs, the blankets may be oriented with the hoses extending upwardly by the thigh. The same complications of different lengths and awkward positioning can occur.
Finally, an ace bandage is wrapped from the toe to the groin with the ends of the two double hoses again being left exposed and extending outwardly from each of the blankets in order to allow the connection to the fluid circulating system. Even the application of the ace bandage is complicated if the initial positioning and wrapping results in the blanket or the ends of the double hoses being poorly positioned.
After surgery, the blanket is normally maintained adjacent the surgical area in the manner described for as long as three to five days prior to the first dressing change. As will be seen, the first dressing change can also be significantly complicated if the blankets, etc. have not been properly positioned after the surgery. Some surgeons believe the surgical area should be cooled for up to 8 days after the surgery. At that time, the gauze pieces, A.B.D. pads, gauze roll, and ace bandage may all be discarded as the knee continues to be treated therapeutically. Without a proper configuration, the blankets could also be discarded prior to therapy. However, if the configuration would not interfere with flexure of the knee, the blanket could be employed to apply heat or cold during therapy.
Because of the problems discussed hereinabove with positioning and maintaining the blankets in alignment with the area to be cooled, some surgeons apply sterile tape directly to the patient's body around the entire circumferential edge of the thermal blanket. Use of this much tape on the body for an extended period of time can result in a deleterious effect on the skin and, particularly, on the skin of elderly patients. Additionally, despite the normal shaving in the area of the surgery, the area to be shaved may be required to be increased because of the application of tape to the thermal blanket. Finally, eventual removal of the tape is extremely painful to many patients.
A primary objective of the invention is to present an improved apparatus for controlling the temperature of the body which is particularly adapted for use in an area following surgery. However, the primary benefit of such an improved apparatus may be the overall reduction in the time required to position and secure the thermal blankets in the operating room. During surgery, the patient is usually anesthetized. It is well known that a primary concern in surgery includes the patient's reaction to and condition when under anesthesia. Any portion of the surgery or post-operative procedure which can reduce the overall time that the patient is under anesthesia is most significant and highly desirable.
Finally, as mentioned hereinabove, a significant number of surgeons do not even attempt to control the temperature in the area of surgery during the post-operative procedure. Because of the complications encountered with the existing systems, many surgeons do not incorporate any means in the post-operative procedures for reducing the temperature in the area of surgery. This occurs despite the clear indication that reducing the temperature in the area of the surgery can reduce the pain, swelling, blood loss of the patient and significantly reduce the time required for the patient to stay in the hospital. As a result, any means which can increase the acceptance and use of the control of the temperature in the surgical area will enable surgeons and hospitals to ultimately benefit an increasing number of patients.
All of the patents discussed hereinabove are incorporated by reference as if the entire contents thereof were included herein.